US8465413B2 - Method of treating Peyronie's disease - Google Patents
Method of treating Peyronie's disease Download PDFInfo
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- US8465413B2 US8465413B2 US12/954,633 US95463310A US8465413B2 US 8465413 B2 US8465413 B2 US 8465413B2 US 95463310 A US95463310 A US 95463310A US 8465413 B2 US8465413 B2 US 8465413B2
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- 238000000034 method Methods 0.000 title claims abstract description 22
- 208000004362 Penile Induration Diseases 0.000 title claims abstract description 19
- 208000020758 Peyronie disease Diseases 0.000 title claims abstract description 19
- 210000003899 penis Anatomy 0.000 claims abstract description 148
- 239000000463 material Substances 0.000 claims description 27
- 239000013013 elastic material Substances 0.000 description 39
- 238000011282 treatment Methods 0.000 description 23
- 239000004744 fabric Substances 0.000 description 19
- 238000001356 surgical procedure Methods 0.000 description 5
- 238000010586 diagram Methods 0.000 description 4
- 210000003195 fascia Anatomy 0.000 description 4
- 210000001519 tissue Anatomy 0.000 description 4
- 238000013459 approach Methods 0.000 description 3
- 210000005226 corpus cavernosum Anatomy 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 239000002759 woven fabric Substances 0.000 description 2
- 208000004483 Dyspareunia Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 206010056303 Painful erection Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000002500 effect on skin Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 239000007926 intracavernous injection Substances 0.000 description 1
- 238000009940 knitting Methods 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 210000001699 lower leg Anatomy 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920005594 polymer fiber Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000002203 pretreatment Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 239000012748 slip agent Substances 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/41—Devices for promoting penis erection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/41—Devices for promoting penis erection
- A61F2005/411—Penile supports
Landscapes
- Health & Medical Sciences (AREA)
- Reproductive Health (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
A method of treating Peyronie's disease manifested in an erect penis having a first penis side with an unaffected length and a second penis side with an affected length that is shorter than the unaffected length includes attaching an elastic device subcutaneously to the first penis side; and providing the elastic device with a stretch stop that limits elongation of the first penis side to an erection distance that is approximately equal to the affected length of the erect penis.
Description
Peyronie's disease is manifested by an abnormal bend that occurs in the erect penis of the sufferer and can be associated with painful erection and/or painful intercourse.
Peyronie's disease is related to the development of scar tissue, or plaques, that form on tissues (e.g., tunica albuginea) inside the penis. One non-surgical approach for the treatment of Peyronie's disease includes injecting drugs into the plaques that lessen the compression applied by the plaques to the erect penis. The research and efficacy of this approach is limited.
Surgical treatments for Peyronie's disease include excising portions of the tunica albuginea from the penis opposite the plaque and closing the fenestrations with sutures. Access to the tunica albuginea is achieved by first degloving the penile skin away from the penis to expose the Buck's fascia and tunica albuginea along the length of the penis. Degloving the penile skin is painful and the recovery time for the patient can be several weeks. Although the long term results of this surgical approach are good, both short term (within 8 weeks) and long term failures can present with residual penile deformity.
Another surgical treatment includes corporal plication in which plication sutures are placed on the contralateral side of the plaque without excising the tunica albuginea or removing the plaque. Corporal plication is most commonly employed subsequent to a previous Peyronie's treatment surgery to correct small angles of residual penile deformity.
Patients and clinicians desire more effective and less invasive surgical treatments for Peyronie's disease.
One aspect provides a Peyronie's treatment device configured to treat an erect penis having curvature characterized by a first penis side with an unaffected length and a second penis side with an affected length that is shorter than the unaffected length. The device includes a band connected between a proximal support that is attachable to a base of a penis and a distal support that is attachable adjacent a corona of the penis. The band has an elastic material and a second material that is attached to the elastic material. The second material is provided to stop elongation of the elastic material at a length approximately equal to the affected length of the erect penis.
One aspect provides a method of treating Peyronie's disease manifested in an erect penis having a first penis side with an unaffected length and a second penis side with an affected length that is shorter than the unaffected length. The method includes attaching an elastic device subcutaneously to the first penis side; and providing the elastic device with a stretch stop that limits elongation of the first penis side to an erection distance that is approximately equal to the affected length of the erect penis.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
Soft tissue includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes but does not include bone.
The term “proximal” as employed in this application means that part that is situated next to or near the point of attachment or origin or a central point: as located toward a center of the human body. The term “distal” as employed in this application means that part that is situated away from the point of attachment or origin or the central point: as located away from the center of the human body. A distal end is the furthest endmost location of a distal portion of a thing being described, whereas a proximal end is the nearest endmost location of a proximal portion of the thing being described. For example, the glans penis is located distal and of the crus of the penis is located proximal relative to the male body such that a distal end of a corpora cavernosum of the patient extends about midway into the glans penis.
Embodiments provide an internal traction device that treats the effects of Peyronie's disease by reducing the curvature of an erect penis. In one embodiment, the device is attached subcutaneously to an exterior surface of the tunica albuginea on a contralateral side of the penis opposite the side on which the Peyronie's plaques have formed and functions to counteract the asymmetrical contraction of the penis caused by the Peyronie's plaques. The device is fabricated from a stretchy material that accommodates movement of the penis between a flaccid state and an erect state. The device is configured to stretch and elongate up to a built-in stop-limit that is selected to match the length of the penis on the side on which the Peyronie's plaques have formed. In this manner, all sides of the penis elongate to an approximately equal length.
In one embodiment, the device is attached to the tunica albuginea of the penis without incising the tunica or removing the Peyronie's plaques, and thus use of the device limits patient discomfort and reduces the healing time for the Peyronie's-afflicted patient compared to other procedures.
Patients who suffer from Peyronie's disease develop a curvature in the erect penis characterized by one side of the penis having an unaffected length and, generally, an opposite side of the penis having an affected length that is shorter than the unaffected length of the penis. The band 20 provides a length that is selected to stretch between a first initial length L1 extending between a base of the penis and a corona of the penis when the penis is flaccid to a final length L2 (FIG. 2 ) that is approximately equal to be affected length of the penis. The elastic material 22 is thus configured to move with the penis between its flaccid state and its erect state, and when the penis is erect, the device 20 is configured to straighten the penis to an approximately symmetric shape/length.
In one embodiment, the second material 28 provides a stop for the elastic material 22 that allows the elastic material 22 to stretch from the initial length L1 to the final length L2, where the final length L2 is selected prior to surgery to be approximately equal to the affected length of the Peyronie's-affected erect penis. In one embodiment, the second material 28 provides means for limiting elongation of the stretchable band 20 to a distance that is greater than the affected length of the Peyronie's-affected erect penis.
In one embodiment, the band 20 is elastically deformable between the initial length L1 and the final length L2 and the second material 28 configures the band 20 to be inelastically deformable past the final length L2. That is to say, the band 20 is stretchable up to the final length L2, and if a sufficiently large force is applied to the band 20 to stretch it beyond the length L2, the band will fracture or otherwise break. Thus, the elastic material 22 is stretchable from the initial length L1 that is less than the affected length to a length that is greater than the affected length, and the second material 28 prevents elongation of the elastic material 22 past the affected length.
In one embodiment, the elastic material 22 is provided as a knitted fabric and the second material 28 is provided as a separate fabric 28 that is attached to the knitted fabric 22, where the separate fabric 28 has some limited degree of stretch that allows the elastic material 22 to stretch up to the desired the final length L2 before the separate fabric 28 stops the elongation of the elastic material 22 at the final length L2. The separate fabric 28 thus allows the elastic material 22 to stretch up to but not beyond the final length L2. With this in mind, one embodiment of the band 20 includes stretching the elastic material 22 to the final length L2 and attaching the separate fabric 28 to the elastic material 22. When the elastic material 22 is relaxed the separate fabric 28 moves with the elastic material 22. When the elastic material 22 is stretched, the separate fabric 28 moves to allow the elastic material 22 to stretch up to but not beyond the final length L2.
In one embodiment, the elastic fabric 22 is provided as a knitted fabric and the second material 28 is provided as an inelastic woven fabric that is attached to the knitted fabric. In one embodiment, the inelastic woven fabric 28 has a fixed length generally equal to L2 and is attached to the elastic fabric 22 in a manner (similar to that described above) that allows the elastic material 22 to stretch up to but not beyond the final length L2.
In one embodiment, the elastic material 22 is provided as a knitted fabric and the second material 28 is provided as inelastic strand 28 embedded in the knitted fabric. As an example, the elastic material 22 is stretched to the final length L2 and the inelastic strand 28 is attached to the elastic material 22 to limit its elongation. In one embodiment, the inelastic strand 28 is fixed to the elastic fabric 22 in a manner that allows the elastic material 22 to stretch up to but not beyond the final length L2.
The elastic material 22 is stretchable between the initial length L1 and a length that is longer than the final length L2, and a second material 28 is provided to stop the elongation of the elastic material 22 at the final length L2. The knitted fabrics of the elastic material 22 are suitably fabricated from polymer fiber such as polypropylene, polyethylene, or polyolefin or such fibers coated with slip agents or elastic additives. The second material 28 is suitably fabricated from, as an example, nylon thread(s) woven or otherwise processed to provide a stop to the elongation of the elastic material 22 at the final length L2. The second material 28 is suitably fabricated from an inelastic suture filament.
Knitted fabrics are generally fabricated from a filament that is knit on a path to form a chain of loops, where each loop in the chain of loops is suspended by a neighboring loop. The loops are secured as they are knit by passing a newly formed loop through a previously formed loop. The chain of loops that run in a lateral direction are referred to as a wale, and the path that the knitting filament follows is referred to as a course (see FIG. 4B as an example of a knitted fabric).
A woven material is different from a knitted material in that woven material is formed by threads that run parallel in a lengthwise direction (warp threads) and cross with a separate set of parallel threads placed in a crosswise direction (weft threads). Woven materials can thus be fabricated that have little or no stretch as the warp and weft threads connect together to limit their mutual movement. In contrast, the meandering course that forms the loops of a knitted material provide the knit with greater elasticity (e.g., stretchiness) over the woven material since the loops move within each other.
With the above mind, the device 20 or the band 20 is provided in multiple formats (for example, each with a different final length L2) that allow the surgeon to select the desired final length L2 as based on the affected length of the erect penis of the patient suffering from Peyronie's disease.
In one embodiment, the band 20 is attached subcutaneously to the tunica albuginea TA of a flaccid penis P. For example, the band 20 is provided in a variety of lengths that allows the surgeon to selective a band 20 having the appropriate initial length L1 and an appropriate final length L2 based on pre-treatment measurements, and knowing these lengths, the surgeon selects the appropriately sized band 20 for attachment to the flaccid penis P.
Alternatively, in one embodiment the band 20 is attached subcutaneously to the tunica albuginea TA of an erect penis P. For example, the surgeon artificially induces an erection in the penis P to observe the angle and extent of the curvature in the Peyronie's affected penis, and after recording this data, selects a band 20 having a final elongated length L2 that is approximately equal to the affected length La of the erect penis. The selected band 20 is attached to the erect penis to provide a suitable amount of correction to the curvature of the Peyronie's affected penis P.
In one embodiment, the proximal support 54 is provided as a segment that is attachable to less than an entire circumference of the base of the penis P. In one embodiment, the distal support 56 is provided as a segment that is attachable to less than an entire circumference of the penis adjacent the corona.
In one embodiment, the proximal support 64 is provided as a continuous ring that is attachable around an entire circumference of the base of the penis P and the distal support 66 is provided as a continuous ring that is attachable around an entire circumference of the penis adjacent the corona.
The following example illustrates, with reference to FIG. 3A , the surgical placement of one of the Peyronie's treatment devices described above without degloving the penile skin.
The patient is anesthetized and surgically draped to define a sterile operating field in an appropriate manner.
The surgeon forms a circumcoronal incision adjacent to the glans penis and a penoscrotal incision adjacent to the base of the penis P. The dartos fascia is reflected to expose the Buck's fascia, and the Buck's fascia is incised down to the tunica albuginea.
The surgeon introduces a flat-bladed tool subcutaneous to the penis over the tunica albuginea and forms a pathway extending from the penoscrotal incision to the circumcoronal incision along the unaffected side 42 of the penis P.
In one embodiment, an artificial erection is imparted to the penis P with an intracavernous injection of saline solution and the surgeon proceeds to attach one of the above-described Peyronie's treatment devices to an exterior surface of the tunica albuginea on a contralateral side of the penis opposite the side on which the Peyronie's plaques have formed.
The proximal support 24 is attached to the base of the penis P, for example with one or more sutures. The flat-bladed tool, or a forceps, is employed to deliver the distal support 26 to a location adjacent a corona of the penis. The surgeon corrects the curvature in the penis P (e.g., manually) and attaches the distal support 26 to the penis at a location that conforms the unaffected side 42 of the penis P to have a length that approximates a length of the affected side 40 of the penis P. In this manner, the implanted Peyronie's treatment device corrects the curvature in the penis.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
Claims (5)
1. A method of treating Peyronie's disease manifested in an erect penis having a first penis side with an unaffected length and a second penis side with an affected length that is shorter than the unaffected length, the method comprising:
attaching an elastic device subcutaneously to the first penis side; and
providing the elastic device with a stretch stop that limits elongation of the first penis side to an erection distance that is approximately equal to the affected length of the erect penis.
2. The method of claim 1 , comprising attaching the elastic device subcutaneously to the first penis side between external skin of the penis and a tunica albuginea of the penis.
3. The method of claim 1 , comprising providing an elastic band connected between a proximal support that is attachable to a base of the penis and a distal support that is attachable adjacent a corona of the penis.
4. The method of claim 3 , comprising providing the elastic band with a second material that is attached to the elastic band, the second material configured to stop elongation of the elastic band.
5. A method of treating Peyronie's disease manifested in an erect penis having a first penis side with an unaffected length and a second penis side with an affected length that is shorter than the unaffected length, the method comprising:
incising skin on the first penis side and accessing the tunica albuginea;
creating an artificial erection in the penis;
attaching a proximal end of an elastic device to a base of the penis on the first penis side;
straightening the penis to reduce a curvature in the erect penis; and
attaching a distal end of the elastic device adjacent to a corona of the penis on the first penis side to maintain the reduced curvature in the erect penis;
wherein the elastic device includes a stretch stop that limits elongation of the first penis side to an erection distance that is approximately equal to the affected length of the erect penis.
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
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US12/954,633 US8465413B2 (en) | 2010-11-25 | 2010-11-25 | Method of treating Peyronie's disease |
US13/189,580 US8206282B2 (en) | 2010-11-24 | 2011-07-25 | Peyronie's treatment device |
EP11794630.1A EP2642949B1 (en) | 2010-11-24 | 2011-11-24 | Peyronie's treatment device |
PCT/DK2011/050448 WO2012069060A1 (en) | 2010-11-24 | 2011-11-24 | Peyronie's treatment device |
ES11794630.1T ES2560629T3 (en) | 2010-11-24 | 2011-11-24 | Peyronie's disease treatment device and Peyronie's disease treatment method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US12/954,633 US8465413B2 (en) | 2010-11-25 | 2010-11-25 | Method of treating Peyronie's disease |
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US13/189,580 Continuation US8206282B2 (en) | 2010-11-24 | 2011-07-25 | Peyronie's treatment device |
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US20120136206A1 US20120136206A1 (en) | 2012-05-31 |
US8465413B2 true US8465413B2 (en) | 2013-06-18 |
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US10729403B2 (en) | 2010-12-14 | 2020-08-04 | Hologic, Inc. | System and method for fusing three dimensional image data from a plurality of different imaging systems for use in diagnostic imaging |
US10956701B2 (en) | 2016-05-27 | 2021-03-23 | Hologic, Inc. | Synchronized surface and internal tumor detection |
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CN104096157A (en) * | 2014-07-15 | 2014-10-15 | 王子锋 | Traditional Chinese medicine for treating induration of penis and preparation method thereof |
US20180177625A1 (en) * | 2016-11-22 | 2018-06-28 | Wei Zhang | Apparatus and method for treating male impotence |
WO2020102120A1 (en) * | 2018-11-16 | 2020-05-22 | Lamamed Solutions | Systems and methods for providing penile modeling |
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